Moxonidine + Perindopril in Hypertensive Patients With Metabolic Syndrome

NCT04023565 | Unknown Phase 4

• 1 other identifier: MOXOD001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of study is to assess the angioprotective effects of antihypertensive combination therapy with perindopril 10 mg and moxonidine 0.4-0.6 mg in patients with arterial hypertension, metabolic syndrome, and obesity, who had Pulse Wave Velocity (PWV) \> 10 m/s on the previously administered two-component combination antihypertensive therapy. Open-label non-comparative prospective study for 24 week for each patient.

Conditions

Arterial Hypertension; Metabolic Syndrome

Keywords

perindopril; moxonidine

Outcome Measures

Primary Outcomes (3)

• Change in Pulse wave velocity (PWV)

  To assess the PWV after 24 weeks of combination treatment with perindopril 10 mg and moxonidine 0.4-0.6 mg against baseline level.

  baseline and 24 weeks

• Change in Central Blood Pressure (BP)

  To assess the central BP changes (systolic BP, aortic pulse BP) after 24 weeks of combination treatment with perindopril 10 mg and moxonidine 0.4-0.6 mg against baseline levels.

  baseline and 24 weeks

• Change in Reflected wave index

  To assess the reflected wave index after 24 weeks of combination treatment with perindopril 10 mg and moxonidine 0.4-0.6 mg against baseline level.

  baseline and 24 weeks

Secondary Outcomes (6)

• Change in carbohydrate and lipid metabolism parameters markers

  baseline and 24 weeks

• Change in the adipokine level

  baseline and 24 weeks

• Change in the Inflammatory marker level

  baseline and 24 weeks

• Change in the renin-angiotensin-aldosterone system hyperactivation marker level

  baseline and 24 weeks

• Change in the sympathoadrenal system hyperactivation marker levels

  baseline and 24 weeks

Study Arms (1)

perindopril + moxonidine

EXPERIMENTAL

perindopril 10 mg + moxonidine 0.4 or 0.6 mg a day (given as two divided doses).

Drug: perindopril + moxonidine

Interventions

perindopril + moxonidine DRUG

After 14 days of wash-out period perindopril 10 mg + moxonidine 0.4 mg a day will be prescribed. If target BP is achieved after 4 weeks, the dosage will remain unchanged (perindopril 10 mg + moxonidine 0.4 mg a day (given as two divided doses). If target BP is not achieved after 4 weeks, the dosage will increase up to perindopril 10 mg + moxonidine 0.6 mg a day (given as two divided doses).

perindopril + moxonidine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients (male and female) aging 18 to 70 years.
• Grade 1, 2 AH (SBP 140-179 mm Hg and/or DBP 90-109 mm Hg according 2018 ESH/ESC guidelines)
• PWV \> 10 m/s
• Previous two-component antihypertensive therapy (ACEi/ARB+ diuretic (HCTZ or indapamide) or ACEI/ARB + amlodipine) during at least 6 months prior to the study enrollment
• Metabolic syndrome diagnosed by the 2009 Russian Society of Cardiology (RSC) National Guidelines criteria
• THE MAIN SIGN: central (abdominal) obesity defined as waist circumference (WC) above 80 cm in women and above 94 cm in men.
• ADDITIONAL CRITERIA:
• i. - arterial hypertension (BP ≥ 130/85 mm Hg) ii. - high triglycerides (≥ 1.7 mmol/l) iii. - decreased HDL-cholesterol (\<1.0 mmol/l for men; \<1.2 mmol/l for women) iv. - increased LDL-cholesterol \> 3.0 mmol/l v. - fasting hyperglycaemia (fasting plasma glucose ≥ 6.1 mmol/l) vi. - impaired glucose tolerance (plasma glucose at 2 hours after glucose load from ≥7.8 to ≤11.1 mmol/l)
• Metabolic syndrome is defined as presence of central obesity and two of the additional criteria.
• Body Mass Index (BMI) \>30 kg/m2.
• For female patients with childbearing potential: negative pregnancy test and willingness to use reliable methods of contraception until the study treatment completion
• Voluntarily signed informed consent to participate in the study.

You may not qualify if:

• Contraindications for using ACEi and imidazoline receptor agonists.
• Administration of perindopril or moxonidine during 6 months before the study onset.
• Metformin therapy for prophylaxis diabetes mellitus type 2 in patients with pre-diabetes, which had been started within 6 months before the study enrollment. (If a patient receives metformin for a long time, i.e., more than 6 months, he/she can be included in the study, and metformin discontinuation is not required).
• Statin and/or fibrate therapy started within 6 months before the study enrollment. (If a patient receives statins and/or fibrates for a long time, i.e., more than 6 months, he/she can be included in the study, and discontinuation of statins and fibrates is not required).
• Current diagnosis of unstable angina, acute and subacute myocardial infarction.
• Heart failure of any functional class.
• Grade 3 AH (≥ 180/110 mm Hg).
• Sinus bradycardia (heart rate ≤50/min).
• Type 1 or 2 diabetes mellitus.
• Severe comorbidities, including mental diseases.
• Acute conditions (infections, exacerbation of chronic diseases, injuries, surgical interventions).
• Alcohol abuse.
• Pregnancy and lactation.
• Serious renal dysfunction (Estimated Glomerular Filtration Rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) ≤30 ml/min/1.73 m2).
• Serious hepatic dysfunction

Sponsors & Collaborators

• Sergey V. Nedogoda: lead

Study Sites (1)

Dept. of Therapy and Endocrinology

Volgograd, 400131, Russia

RECRUITING

MeSH Terms

Conditions

Hypertension; Metabolic Syndrome

Interventions

Perindopril; moxonidine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sergey V. Nedogoda, Professor

  Volgograd State Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sergey V. Nedogoda, Professor

CONTACT

+79023643226; nedogodasv@rambler.ru

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.Med.Sc., Professor

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: July 17, 2019
• Study Start: March 11, 2019
• Primary Completion: June 30, 2020
• Study Completion: December 30, 2020
• Last Updated: July 23, 2019

Record last verified: 2019-07

Locations

RU (1)